Effects of Infra- and Ultrasound on the Brain

NCT03459183 | Completed

• 1 other identifier: SonicBrain01
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Findings in neuroscientific research show that the environment one lives in has measurable effects on brain morphology and functioning. Human exposure to airborne infra- and ultrasound has been constantly increasing during the last decades. For instance, the European Renewable Energy Directive, established in 2009, lead to an increased use of wind turbines, generating infrasound. The EU Directive states that until 2020 a 20% of the EUs' total energy needs is to be generated with renewables, therefore the current infrasound load in the European environment will increase further. Similarly, ultrasound is ubiquitous in the modern public environment, emitted from public address systems, animal repellents, industrial machines, even toothbrushes. The present study aims to investigate potential long-term effects of exposure to infra- and ultrasound on subjective well-being, cognitive and brain functioning, as well as on brain structure. The study will apply a randomized-(placebo) controlled single-blind approach to investigate this subject.

Conditions

Brain Function; Ultrasound; Cognitive Function; Well-being; Depression; Sleep

Outcome Measures

Primary Outcomes (7)

• Changes in functional connectivity (functional Magnet Resonance Imaging; fMRI)

  exploratory analyses of functional brain changes (fMRI) through infra- and ultrasound (verum conditions vs. placebo conditions)

  at baseline (day 0) and after exposure to infra-/ ultrasound (day 28+)

• Changes in brain structure (MRI)

  exploratory analyses of structural brain changes (MRI) through infra- and ultrasound (verum conditions vs. placebo conditions)

  at baseline (day 0) and after exposure (day 28+)

• Changes in depression levels

  changes in Beck's Depression Inventory - II - revised sum scores, indicating a worsening or improvement (increase or decrease in sum scores) of depression through infra- and ultrasound (verum conditions vs. placebo conditions).

  at baseline (day 0) and after exposure (day 28+)

• Changes in 'vigilance' attentional test score

  worsening or improvement in the maintenance of attention over a prolonged period of time (this is operationalized as a decrease or increase in the number of correct responses; minimum = 0, maximum = 36; assessed by TAP - Test of Attentional Performance: subtest 'vigilance') through infra- and ultrasound (verum conditions vs. placebo conditions).

  at baseline (day 0) and after exposure (day 28+)

• Changes in memory test score

  worsening or improvement in memory performance (as indicated by the total score in the fMRI spatial n-back task, defined as the absolute number of correct responses \[i.e. correct identification of overlapping dot position; minimum of correct responses = 0, maximum = 100\], a decrease indicates worsened spatial memory, an increase indicates improved spatial memory; through infra- and ultrasound (verum conditions vs. placebo conditions).

  at baseline (day 0) and after exposure (day 28+)

• Changes in alertness task score

  worsening or improvement in 'alertness' (as indicated by mean reaction time \[RT\] to target stimuli; higher mean RT indicates lowered alertness = worsening; lower mean RT indicates improvement in alertness, \[TAP - Test of Attentional Performance; subtest 'alertness'\]), through infra- and ultrasound (verum conditions vs. placebo conditions).

  at baseline (day 0) and after exposure (day 28+)

• Changes in sleep quality

  worsening or improvement in self-reported sleep quality (decreases or increases in sum score of the Pittsburgh Sleep Quality Index) through infra- and ultrasound (verum conditions vs. placebo conditions).

  at baseline (day 0) and after exposure (day 28+)

Secondary Outcomes (1)

• Changes in somatization (physical health)

  at baseline (day 0) and after exposure (day 28+)

Study Arms (4)

Infrasound - verum

EXPERIMENTAL

In this condition, participants are exposed with non-audible infrasound from the Infrasound (85dB; 6Hz) source, for 8 constant hours during their night sleep. The source is placed close to the participant's bed (approximately 1-2 meters).

Device: Infrasound (85 dB; 6Hz) source

Infrasound - placebo

PLACEBO COMPARATOR

In this condition, participants are not exposed to any sound. The infrasound dummy source is placed close to the participant's bed, exactly like in the Infrasound - verum condition (1-2 meters). The Infrasound dummy source looks exactly like the active infrasound source but produces no sound at all. Participants are told that this source emits sound for 8 constant hours during their night sleep.

Device: Infrasound dummy source

Ultrasound - verum

EXPERIMENTAL

In this condition, participants are exposed to non-audible ultrasound, emitted by the Ultrasound (10dB below hearing threshold; 22.4 kHz) source for 8 constant hours during their night sleep. The source is placed close to the participant's bed (1-2 meters), at the level of the participant's head (for instance on a nightstand).

Device: Ultrasound (10dB below hearing threshold; 22.4 kHz) source

Ultrasound - placebo

PLACEBO COMPARATOR

In this condition, participants are not exposed to any sound. The Ultrasound dummy source is placed close to the participant's bed, exactly like in the Infrasound - verum condition (1-2 meters). The Ultrasound dummy source looks exactly like the active ultrasound source, but produces no sound at all. Participants are told that this source emits sound for 8 constant hours during their night sleep.

Device: Ultrasound dummy source

Interventions

Infrasound (85 dB; 6Hz) source DEVICE

the infrasound source will emit inaudible 6Hz sound for 8 consecutive hours during participant's night sleep, local sound pressure (at participants head) will be calibrated at 85 dB

Infrasound - verum

Ultrasound (10dB below hearing threshold; 22.4 kHz) source DEVICE

the ultrasound source will emit inaudible 22.4 kHz sound for 8 consecutive hours during night sleep

Ultrasound - verum

Infrasound dummy source DEVICE

the infrasound dummy source looks exactly like the according verum infrasound source but produces absolutely no sound

Infrasound - placebo

Ultrasound dummy source DEVICE

the ultrasound dummy source looks exactly like the according verum ultrasound source but produces absolutely no sound

Ultrasound - placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy participants
• age 18-40
• informed consent for all parts of the study (including MRT)

You may not qualify if:

• normal hearing
• age \< 18 or \> 40 years
• pregnancy or breastfeeding
• living with young children (0-3 years)
• pets in sleeping room (e.g. cats, dogs, rodents, reptiles)
• living at extremely loud/ noisy street
• tinnitus
• chronic disease/ infection of ENT region
• ear deformation/ ear surgery
• (partial) deafness
• hearing aid/ cochlea implant
• degenerative or inflammatory diseases of the central nervous system
• severe cognitive/ neuropsychological impairment
• severe pain syndrome or other severe organic diseases
• epilepsy

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• European Union: collaborator

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Psychiatrie und Psychotherapie, Hamburg, Germany

Hamburg, 20246, Germany

Location

Related Publications (7)

• Weichenberger M, Bauer M, Kuhler R, Hensel J, Forlim CG, Ihlenfeld A, Ittermann B, Gallinat J, Koch C, Kuhn S. Altered cortical and subcortical connectivity due to infrasound administered near the hearing threshold - Evidence from fMRI. PLoS One. 2017 Apr 12;12(4):e0174420. doi: 10.1371/journal.pone.0174420. eCollection 2017.

  PMID: 28403175 BACKGROUND

• Weichenberger M, Kuhler R, Bauer M, Hensel J, Bruhl R, Ihlenfeld A, Ittermann B, Gallinat J, Koch C, Sander T, Kuhn S. Brief bursts of infrasound may improve cognitive function--an fMRI study. Hear Res. 2015 Oct;328:87-93. doi: 10.1016/j.heares.2015.08.001. Epub 2015 Aug 7.

  PMID: 26260309 BACKGROUND

• Yoo SS, Kim H, Min BK, Franck E, Park S. Transcranial focused ultrasound to the thalamus alters anesthesia time in rats. Neuroreport. 2011 Oct 26;22(15):783-7. doi: 10.1097/WNR.0b013e32834b2957.

  PMID: 21876461 BACKGROUND

• Baliatsas C, van Kamp I, van Poll R, Yzermans J. Health effects from low-frequency noise and infrasound in the general population: Is it time to listen? A systematic review of observational studies. Sci Total Environ. 2016 Jul 1;557-558:163-9. doi: 10.1016/j.scitotenv.2016.03.065. Epub 2016 Mar 17.

  PMID: 26994804 BACKGROUND

• Leventhall, G., Pelmear, P., and Benton, S., 2003, A review of published research on low frequency noise and its effects: Department for Environment, Food and Rural Affairs.

  BACKGROUND

• Smagowska B, Pawlaczyk-Luszczynska M. Effects of ultrasonic noise on the human body-a bibliographic review. Int J Occup Saf Ergon. 2013;19(2):195-202. doi: 10.1080/10803548.2013.11076978.

  PMID: 23759188 BACKGROUND

• Ascone L, Kling C, Wieczorek J, Koch C, Kuhn S. A longitudinal, randomized experimental pilot study to investigate the effects of airborne ultrasound on human mental health, cognition, and brain structure. Sci Rep. 2021 Mar 12;11(1):5814. doi: 10.1038/s41598-021-83527-z.

  PMID: 33712644 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Christian Koch, Dr.

  Physikalisch-Technische Bundesanstalt, Braunschweig, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know their group assignment (ultrasound - verum, ultrasound - placebo; infrasound - verum, infrasound - placebo).
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: March 8, 2018
• Study Start: May 31, 2018
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2019
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

DE (1)